Trials / Active Not Recruiting
Active Not RecruitingNCT06697626
Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's Disease
Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- University of Ulster · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. Inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with PD. With the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including B-vitamins and vitamin D (which are suggested within the literature to be beneficial in PD). Therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with PD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Inulin, B-vitamins and vitamin D | Intervention twice daily with: 10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D |
| DIETARY_SUPPLEMENT | Placebo group | A twice daily placebo drink with similar energy content but without the additional nutrient provision |
Timeline
- Start date
- 2024-11-14
- Primary completion
- 2026-05-01
- Completion
- 2026-11-01
- First posted
- 2024-11-20
- Last updated
- 2026-02-25
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06697626. Inclusion in this directory is not an endorsement.